3f® 1000-29 (UDI 00613994868213)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994868213), received between Sep 7, 2017 and Jun 23, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 1 MONTH POST IMPLANT OF THIS 3F AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25590848 ↗
• InjuryFeb 26, 2026Material Split, Cut or Torn; Intravalvular regurgitation

  IT WAS REPORTED THAT 14 YEARS AND 6 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC CENTRAL REGURGITATION. IT WAS FURTHER NOTED EVIDENCE OF POSSIBLE TORN LEAFLET WAS SEEN IN THE VALVE. IT WAS REPORTED THAT AN INTERVENTION IS REQUIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24455906 ↗
• InjuryJun 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 1 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19547772 ↗
• InjuryJul 16, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT SIX YEARS AND ELEVEN MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO SEVERE STENOSIS AND INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Insufficiency, Valvular; Stenosis

  MAUDE report 7690680 ↗
• InjuryJun 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 2 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO SEVERE INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency

  MAUDE report 7650354 ↗
• InjuryMay 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 2 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 7531461 ↗
• InjurySep 7, 2017Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS 5 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO INCREASED GRADIENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6847952 ↗